Rivaroxaban for the treatment of venous thromboembolism

Acute venous thromboembolism (deep vein thrombosis [DVT] or pulmonary embolism) is a common disorder with an annual incidence of approximately 1 or 2 cases per 1000 persons in the general population. Standard treatment is limited by the need for parenteral heparin initially, with overlapping administration of a vitamin K antagonist. This presents a challenge to outpatient management, since treatment with a vitamin K antagonist requires laboratory monitoring and dose adjustment and may be complicated by drug and food interactions. After the first year, the annual risk of major bleeding associated with vitamin K antagonists is 1 to 2% and the benefits of continued therapy remains a subject of debate. Rivaroxaban, an orally active, direct factor Xa inhibitor, does not require laboratory monitoring and in RCTs, as a single agent, is as effective as standard therapy, with similar safety, for the treatment of acute venous thromboembolism. Rivaroxaban furthermore has an acceptable risk of bleeding when used as continued treatment for recurrences prevention, resulting very effective as compared with placebo. The unique aspect of the acute venous thromboembolism studies is the use of rivaroxaban as a single agent, replacing both low-molecular-weight heparin and a vitamin K antagonist in the treatment of DVT. In conclusion, oral rivaroxaban, at a dose of 15 mg twice daily for the first 3 weeks, followed by 20 mg once daily thereafter, without the need for laboratory monitoring, may provide an effective, safe, single-drug approach to the initial and continued treatment of venous thrombosis.